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Enrolling by Invitation

NCT Number: NCT05725967

Endoscopic Metabolic and Bariatric Therapies

This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.

Enrolling by Invitation

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Key information

Conditions

Obesity Abdominal Obesity Abdominal Pain Anastomotic Leak Bariatric Surgery Candidate Body Weight Body Weight Changes Complication of Surgical Procedure Complication of Treatment Complication,Postoperative Delayed Gastric Emptying Following Procedure Digestive System Diseases Digestive System Fistula Duodenal Diseases Fistula Fistula, Gastric Gastric Fistula Gastrointestinal Diseases Intestinal Diseases Leak, Anastomotic Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Associated Disorder Obesity, Abdominal Obesity, Morbid Overnutrition Overweight Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peptic Ulcer Postoperative Complications Roux-en-y Anastomosis Site Signs and Symptoms Signs and Symptoms, Digestive Stomach Diseases Stomach Ulcer Ulcer, Gastric Weight Gain Weight Loss

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

The Investigators will be collecting data on bariatric patients post-bariatric surgery, post-endoscopic revision of bariatric surgical complications and post-endoscopic metabolic and bariatric therapies (including but not limited to roux-en-y gastric bypass, sleeve gastrectomy, laparoscopic adjustable gastric banding, gastroplasty with endoscopic myotomy (GEM), endoscopic sleeve gastroplasty (ESG), transoral outlet reduction (TORe), primary obesity surgery endoluminal (POSE), restorative obesity surgery endoluminal (ROSE), intragastric balloons (IGB), aspiration therapy and pylorus sparing antral myotomy) to review demographics, adverse events, medications, radiology, procedure time, cost, comorbidity resolution and resource utilization.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients from Mass General Brigham
  • any patient having an endoscopic primary obesity procedure
  • any patient having an endoscopic post-bariatric surgical revision procedure
  • any patient having a bariatric surgical procedure

Exclusion criteria

  • patients without past surgical and medical history medical records in the Mass General Brigham system
  • patients unwilling to allow for medical record review at Mass General Brigham

Treatment and study plan

Primary Obesity Endoscopic Procedures

Procedure

Any primary endoscopic procedure for treatment of obesity including endoscopic sleeve gastroplasty (ESG), intragastric balloons (IGB), Aspiration therapy, pylorus sparing antral myotomy (PSAM), primary obesity surgery endoluminal (POSE), gastroplasty with endoscopic myotomy (GEM).

Other names: ESG, Aspiration Therapy, IGB, POSE, GEM, PSAM, BEAM, EMBTs

Endoscopic Revision of Bariatric Surgical Procedures

Procedure

Any endoscopic revision procedure in a post-bariatric surgical patient, including transoral outlet reduction (TORe), restorative obesity surgery endoluminal (ROSE), argon plasma coagulation of the outlet (APC), endoscopic suturing.

Other names: TORe, ROSE, APC

Bariatric Surgery Procedures

Procedure

Any bariatric surgical procedure including Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastroplasty (LSG), laparoscopic adjustable gastric banding (LAGB)

Other names: RYGB, LSG, LAGB

Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction

Device

Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.

Other names: ESG, TORe

Intragastric Balloon

Device

An endoscopic bariatric procedure involving the placement of an intragastric balloon.

Other names: IGB

Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal

Device

Any endoscopic procedure using an endoscopic plicating device for primary obesity treatment or revision of post bariatric complications.

Other names: POSE, ROSE

Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy

Device

Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.

Other names: APC, GEM, BEAM, PSAM

Aspiration Therapy

Device

Placement of an aspiration therapy device for the treatment of obesity.

Other names: Aspire

Primary outcomes

  1. Change in weight from pre-procedure to 10 years

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    %TBWL

  2. Change in hypertension from pre-procedure to 10 years using blood pressure measurements

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change of hypertension status by comparing blood pressure measurements (systolic/diastolic mmHg) from baseline.

  3. Change in hypertension from pre-procedure to 10 years using medication dosages

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change of hypertension status by comparing change in dosage (mg) of hypertension medications from baseline.

  4. Change in medication dosage to determine change in diabetes status from pre-procedure to 10 years

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change of diabetes status by comparing change in dosage (mg) of diabetes medications from baseline to 10 years.

  5. Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change of HgA1c (%) by comparing lab values from baseline through 10 years.

  6. Change in total cholesterol lab values (mg/dL) from pre-procedure to 10 years

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change in total cholesterol measurements by comparing followup lab values (mg/dL) to baseline.

  7. Change in low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 years

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change in LDL measurements by comparing followup lab values (mg/dL) to baseline.

  8. Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 years

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change in HDL measurements by comparing followup lab values (mg/dL) to baseline.

  9. Change in medication dosage (mg) to determine change in total cholesterol (mg/dL) from pre-procedure to 10 years

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change in total cholesterol measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

  10. Change in medication dosage (mg) to determine change in High Density Lipoprotein (HDL) (mg/dL) from pre-procedure to 10 years

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change in HDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

  11. Change in medication dosage (mg) to determine change in Low Density Lipoprotein (LDL) (mg/dL) from pre-procedure to 10 years

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change in LDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

  12. Change in rate of adverse events from procedure to 10 years

    Time frame: Procedure, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change in rate of adverse events post-procedure through 10 years

  13. Change in comorbidity medication dosages from baseline to 10 years

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change of dosage of comorbidity medications compared to baseline

Secondary outcomes

  1. Change in gastric motility from baseline to 10 years

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Gastric emptying breath test

  2. Change in PYY gut hormones from baseline to 10 years

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

    PYY lab values will be compared to baseline

  3. Change in GLP1 gut hormones from baseline to 10 years

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

    GLP1 lab values will be compared to baseline

  4. Change in ghrelin hormones from baseline to 10 years

    Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Ghrelin lab values will be compared to baseline

  5. Cost comparison of procedural costs associated with bariatric endoscopic vs. surgical procedures from baseline to 10 years

    Time frame: Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery

    Cost-effectiveness analysis of procedure costs from admission to discharge for endoscopic vs. surgical bariatric procedures

Sponsors and collaborators

Lead sponsor

Christopher C. Thompson, MD, MSc

Other

Registry information

Acronym: EMBTs

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Feb 13, 2023
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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